Senior Associate, Regulatory Strategy – Infectious Diseases, Biological Products

🔥 2 minutes ago

🌐 Mexico, Peru, +2 more countries – Remote

🇲🇽 Mexico – Remote 🇵🇪 Peru – Remote 🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Support the Director, Regulatory Affairs & Quality Assurance, in executing regulatory strategies and priorities for product lifecycle • Perform initial regulatory impact assessments for proposed global changes and recommend submission requirements, sequencing, dependencies, documentation needs, and timelines • Identify and assess regulatory risks, issues, dependencies, and potential delays; escalate them with proposed mitigation actions • Monitor regulatory requirements, COFEPRIS criteria, procedural updates, and emerging practices; provide regulatory intelligence and impact assessments • Support regulatory procedures before COFEPRIS, including preparation and follow-up of submissions, responses to queries, commitments, and post-approval activities • Coordinate labeling and artwork regulatory activities, including local prescribing information, packaging components, approved conditions, and safety-related updates • Maintain an integrated regulatory portfolio covering registrations, submissions, approvals, commitments, renewals, post-approval changes, authority requests, dependencies, and milestones • Maintain regulatory plans, submission schedules, trackers, and status reports; provide operational updates • Own assigned regulatory activities end-to-end, driving inputs, timelines, document readiness, follow-up, and closure • Coordinate regulatory assessments and execution of CMC and manufacturing-related changes • Collaborate with Global Regulatory CMC, Quality, and Supply Chain teams • Maintain regulatory records, submissions, approvals, correspondence, and commitments in applicable systems and repositories • Support local Quality activities, compliance requirements, quality events, inspection readiness, and audit readiness • Coordinate with Global Regulatory, Regional Regulatory, Medical, Pharmacovigilance, Supply Chain, Quality, Commercial, and other cross-functional partners • Escalate strategic decisions, material risks, and authority-sensitive matters to the Director

🎯 Requirements

• BA/BS degree in a scientific, engineering, or healthcare discipline • 5+ years of experience in the pharmaceutical industry, preferably in LATAM countries • 3+ years of experience in regulatory strategy or relevant training/experience • Exceptional written and oral communication in English and Spanish • Strong knowledge of current US and EU regulations • Strong experience with CTD format and content of regulatory filings • Knowledge and broad experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance • Demonstrated strong organizational skills, including the ability to prioritize workload • Experience in the preparation of regulatory submissions and supportive amendments or supplements • Experience authoring regulatory documents • Knowledge and understanding of applicable regulations • Preferred: Masters, PharmD, or PhD degree • Preferred: Experience in Infectious Diseases and Biologicals • Preferred: Experience working on products in development, specifically relating to clinical and pre-clinical regulatory aspects • Preferred: Experience with regulatory procedures and legislation from both US and EU markets

🏖️ Benefits

• No specific benefits, perks, or compensation extras stated